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Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)

Primary Purpose

Obstructive Sleep Apnea, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Olmesartan and Azelnidipine
Sponsored by
Kyoto University, Graduate School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Continuous positive pressure ventilation, Blood pressure, Oxygen desaturation index, Endothelial dysfunction, Patient reported measurement

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Apnea and hypopnea index of more than 20 /hr, and treated with CPAP
  • Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg

Exclusion Criteria:

  • Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months
  • Uncontrolled arrhythmia
  • Severe hepatic or renal disorders
  • Having poor prognosis disorders such as malignant disorders

Sites / Locations

  • Kirigaoka Tsuda Hospital
  • Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

ARB plus increased ARB

ARB plus CCB

CCB plus ARB

Arm Description

angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months

angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months

calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months

Outcomes

Primary Outcome Measures

Blood pressure

Secondary Outcome Measures

Oxygen desaturation index
Pulse rate
Endothelial dysfunction
Sleep quality and sleepiness
Health-related quality of life

Full Information

First Posted
December 8, 2009
Last Updated
April 1, 2015
Sponsor
Kyoto University, Graduate School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01028534
Brief Title
Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
Official Title
Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University, Graduate School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.
Detailed Description
Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Hypertension
Keywords
Continuous positive pressure ventilation, Blood pressure, Oxygen desaturation index, Endothelial dysfunction, Patient reported measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARB plus increased ARB
Arm Type
Active Comparator
Arm Description
angiotensin II receptor blockers for the first 3 months and increasing dose of angiotensin II receptor blockers for the next 3 months
Arm Title
ARB plus CCB
Arm Type
Active Comparator
Arm Description
angiotensin II receptor blockers for the first 3 months and adding calcium channel blockers for the next 3 months
Arm Title
CCB plus ARB
Arm Type
Active Comparator
Arm Description
calcium channel blockers for the first 3 months and adding angiotensin II receptor blockers for the next 3 months
Intervention Type
Drug
Intervention Name(s)
Olmesartan and Azelnidipine
Other Intervention Name(s)
Olmesartan (angiotensin II receptor blockers: ARB), Azelnidipine (long-acting calcium channel blockers: CCB)
Intervention Description
Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, increase Olmesartan to 40mg per day for the next 3 months Olmesartan 20mg per day for 3 months and, if hypertension is not controlled, add Azelnidipine 16mg per day for the next 3 months Azelnidipine 16mg per day for 3 months, and, if hypertension is not controlled, add Olmesartan 20mg per day for the next 3 months
Primary Outcome Measure Information:
Title
Blood pressure
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Oxygen desaturation index
Time Frame
Six months
Title
Pulse rate
Time Frame
Six months
Title
Endothelial dysfunction
Time Frame
Six months
Title
Sleep quality and sleepiness
Time Frame
Six months
Title
Health-related quality of life
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Apnea and hypopnea index of more than 20 /hr, and treated with CPAP Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg Exclusion Criteria: Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months Uncontrolled arrhythmia Severe hepatic or renal disorders Having poor prognosis disorders such as malignant disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuo Chin, MD, PhD
Organizational Affiliation
Graduate School of Medicine, Kyoto University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Toru Oga, MD, PhD
Organizational Affiliation
Graduate School of Medicine, Kyoto University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kirigaoka Tsuda Hospital
City
Kitakyushu
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
Country
Japan

12. IPD Sharing Statement

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Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)

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